Skip to content

Determination of the degree of epiphyseal fusion using ultrasound.

Determination of the degree of epiphyseal fusion using ultrasound. - KLEVUS (PRIMSA)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025488
Enrollment
582
Registered
2021-06-02
Start date
2016-05-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1: Bone age measurement with ultrasound

Sponsors

Universität des Saarlandes
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 25 Years

Inclusion criteria

Inclusion criteria: - The study participant is able to understand the nature, significance and scope of the clinical study. - An informed consent form personally signed and dated by the study participant or his/her legal representative before any study-specific measure is performed. - Children, adolescents, and young adults =13 and =25 years of age.

Exclusion criteria

Exclusion criteria: - Hypersensitivity to the test product or one of the components of the test products (e.g. ultrasound gel). - Medical or psychological circumstances that may jeopardize the proper conduct of the clinical study. - Injuries that could influence a statement regarding the bone age according to Greulich and Pyle.

Design outcomes

Primary

MeasureTime frame
The primary efficacy endpoint is the clinical success rate of the system in determining the age of majority in subjects of different ethnicities between 13 and 25 years of age.

Secondary

MeasureTime frame
The secondary efficacy point is the system's clinical success rate in determining the age of majority for girls and boys (or young women and men) between the ages of 13 and 25 with additional differentiation of ethnicities or origins.

Countries

Germany

Contacts

Public ContactTilman Rohrer

Klinik für Allgemeine Pädiatrie und Neonatologie

tilman.rohrer@uks.eu06841/16-28315

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026